- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01020942
Cardioprotective Effects of Electroacupuncture Pretreatment Against Coronary Stenting
Cardioprotective of Electroacupuncture Pretreatment in Patients Underwent Coronary Stenting: A Prospective, Multicenter, Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases.Troponin release is a sensitive and specific marker of myocyte necrosis and infarction resulting from a form of ischemia/reperfusion injury, downstream embolization of atheromatous material, and coronary side-branch occlusion. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events.
Transient sublethal episodes of ischemia before a prolonged ischemia/reperfusion injury, known as ischemic preconditioning (IPC), have been shown to reduce the extent of myocardial infarction (MI).Electroacupuncture (EA) stimulus, as a pretreatment method, limits MI size in animal models. However, there are limited outcome to demonstrate protection from EA pretreatment during PCI. The present study investigated the ability of EA pretreatment to attenuate cardiac troponin I (cTnI) release after elective PCI in a single-center, randomized controlled trial.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Xijing Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients > 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study.
Exclusion Criteria:
- Emergency PCI,
- Elevation of cTnI before PCI taken at the preadmission clinic,
- Women of child-bearing age,
- Nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning blocking medication, respectively), and
- Severe comorbidity (estimated life expectancy < 6 months).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
The control patients were only placed needles at the bilateral Neiguan (PC 6)acupoints without electric stimulus.
Other Names:
|
Experimental: Pretreatment
|
According to the theory of traditional Chinese medicine, bilateral Neiguan (PC 6) acupoints were chosen and identified according to traditional anatomical localizations.
Once insertion of original needles was made at the acupoints, the needle was stimulated electrically with the intensity of 2-6 mA and frequency of 2/30 Hz using the Electronic Acupuncture Treatment Instrument until the patient felt the so-called 'Teh Chi' sensation of heaviness, numbness and swelling.
The pretreatment was individualized based on patients sex, age, weight and felt and given 1 time per day for 5 consecutive days before the heart valve replacement surgery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome was assessing whether EA pretreatment before elective PCI reduced cTnI concentration at 48 hours.
Time Frame: 48 hours after PCI
|
48 hours after PCI
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary outcomes were the effect of EA pretreatment on ischemic symptoms, ECG evidence of ischemia during coronary balloon occlusion, CRP,and major adverse cardiac events (MACE) at 6 months.
Time Frame: six months of PCI follow-up.
|
six months of PCI follow-up.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Lize Xiong, M.D., Ph.D., Xijing Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- XJMZK016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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